Maternal Mindfulness to Prevent Depression and Reduce Postpartum Pain (MaMiDaPP) Intervention
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Postpartum depression
研究概览
简要总结
This phase I clinical trial tests the feasibility and safety of a self-guided, mobile mindfulness-based intervention to reduce post-cesarean pain and prevent postpartum depression.
详细描述
Postpartum pain affects approximately 92% of women and is a risk factor for postpartum depression (PPD). Cesarean delivery is associated with elevated risk for both postpartum pain and PPD, and women who experience persistent postpartum pain are at increased risk of developing depressive symptoms. PPD may contribute to withdrawal, emotional detachment, and hostility, which can negatively affect mother-infant interactions, including breastfeeding. These risks underscore the urgent need for an effective non-pharmacologic intervention to reduce post-cesarean delivery pain and prevent PPD. The objective of this study is to optimize a mobile, self-guided 8-week Mindfulness-Based Stress Reduction (MBSR) intervention for non-depressed women at risk for PPD who have a planned cesarean delivery. The investigators will conduct a single-group open trial of women (N = 20), including Latinas (English- and Spanish-speaking), Asian, African American, and non-Hispanic White women. The study is testing two primary hypotheses: (1) the 8-week mobile MBI will demonstrate high feasibility and acceptability among a diverse sample of women, shown by meeting target recruitment, enrollment, and retention benchmarks and (2) participants will demonstrate reductions in reported pain scores and depressive symptoms from pre- to post-intervention. In addition, the study will evaluate recruitment, enrollment, dosage, safety, and retention metrics and survey participants about intervention features, facilitators, barriers, satisfaction, and recommendations.
Participants will be recruited through community partners, including the Champaign-Urbana Public Health District and the University YMCA, using flyers, partner-supported distribution of study information, and email announcements. Interested individuals will complete an online eligibility screener accessed through a QR code or URL on recruitment materials. Eligible participants will include women with an Edinburgh Postnatal Depression Scale score of 5-13 who have a planned singleton cesarean delivery, are within 18-45 years of age, and have no chronic pain condition. Individuals who meet initial eligibility criteria will be contacted by phone to confirm participant authenticity, then sent a REDCap link to complete electronic consent and a background questionnaire. After enrollment, participants will meet briefly with a trained research assistant to review access to the intervention platform and address any questions or concerns. Recruitment and enrollment will occur during the third trimester of pregnancy, and the intervention will begin during the first week following cesarean delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women must self-identify as Latina/Latinx/Hispanic, Asian, African American, or non-Hispanic White.
- •Scheduled to undergo a planned cesarean delivery.
- •Be of 18-45 years of age
- •Have a singleton pregnancy
- •Score between 5 and 13 on the Edinburgh Postnatal Depression Scale (EPDS)
- •A history of depression
- •Have no chronic pain condition (e.g., fibromyalgia)
- •Own a computer, smartphone, or tablet
- •Have a reliable internet access to complete the online surveys.
- •Be proficient in English or Spanish.
排除标准
- •Women who screen 10 or higher on the EPDS
研究组 & 干预措施
Mindfulness
Receiving mobile, self-guided mindfulness intervention
干预措施: Mindfulness (Behavioral)
Treatment as usual with monitoring
Receiving treatment as usual with monitoring by study PI and investigators.
结局指标
主要结局
Postpartum depression
时间窗: 4 weeks - 6 months
depressive symptoms EPDS 13 or higher
Post-operative pain
时间窗: 1 week postpartum and 8 weeks postpartum
Numerical Pain Rating Scale (NPRS); Participant reported pain intensity (0 is equivalent to no pain and 10 indicates the worst possible pain) and pain unpleasantness (0 is equivalent to not at all unpleasant and 10 indicates the most unpleasant feeling possible)
次要结局
- Post-operative pain(4 weeks - 6 months)
- Postpartum depression(1 week postpartum and 8 weeks postpartum)
研究者
Sandraluz Lara-Cinisomo
Associate Professor
University of Illinois at Urbana-Champaign
